02011R0540 — EN — 01.04.2021 — 066.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011

of 25 May 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

(Text with EEA relevance)

(OJ L 153 11.6.2011, p. 1)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) No 541/2011 of 1 June 2011

  L 153

187

11.6.2011

►M2

COMMISSION IMPLEMENTING REGULATION (EU) No 542/2011 of 1 June 2011

  L 153

189

11.6.2011

►M3

COMMISSION IMPLEMENTING REGULATION (EU) No 702/2011 of 20 July 2011

  L 190

28

21.7.2011

►M4

COMMISSION IMPLEMENTING REGULATION (EU) No 703/2011 of 20 July 2011

  L 190

33

21.7.2011

►M5

COMMISSION IMPLEMENTING REGULATION (EU) No 704/2011 of 20 July 2011

  L 190

38

21.7.2011

►M6

COMMISSION IMPLEMENTING REGULATION (EU) No 705/2011 of 20 July 2011

  L 190

43

21.7.2011

►M7

COMMISSION IMPLEMENTING REGULATION (EU) No 706/2011 of 20 July 2011

  L 190

50

21.7.2011

►M8

COMMISSION IMPLEMENTING REGULATION (EU) No 736/2011 of 26 July 2011

  L 195

37

27.7.2011

►M9

COMMISSION IMPLEMENTING REGULATION (EU) No 740/2011 of 27 July 2011

  L 196

6

28.7.2011

►M10

COMMISSION IMPLEMENTING REGULATION (EU) No 786/2011 of 5 August 2011

  L 203

11

6.8.2011

►M11

COMMISSION IMPLEMENTING REGULATION (EU) No 787/2011 of 5 August 2011

  L 203

16

6.8.2011

►M12

COMMISSION IMPLEMENTING REGULATION (EU) No 788/2011 of 5 August 2011

  L 203

21

6.8.2011

►M13

COMMISSION IMPLEMENTING REGULATION (EU) No 797/2011 of 9 August 2011

  L 205

3

10.8.2011

►M14

COMMISSION IMPLEMENTING REGULATION (EU) No 798/2011 of 9 August 2011

  L 205

9

10.8.2011

►M15

COMMISSION IMPLEMENTING REGULATION (EU) No 800/2011 of 9 August 2011

  L 205

22

10.8.2011

►M16

COMMISSION IMPLEMENTING REGULATION (EU) No 806/2011 of 10 August 2011

  L 206

39

11.8.2011

►M17

COMMISSION IMPLEMENTING REGULATION (EU) No 807/2011 of 10 August 2011

  L 206

44

11.8.2011

►M18

COMMISSION IMPLEMENTING REGULATION (EU) No 810/2011 of 11 August 2011

  L 207

7

12.8.2011

►M19

COMMISSION IMPLEMENTING REGULATION (EU) No 820/2011 of 16 August 2011

  L 209

18

17.8.2011

►M20

COMMISSION IMPLEMENTING REGULATION (EU) No 974/2011 of 29 September 2011

  L 255

1

1.10.2011

►M21

COMMISSION IMPLEMENTING REGULATION (EU) No 993/2011 of 6 October 2011

  L 263

1

7.10.2011

►M22

COMMISSION IMPLEMENTING REGULATION (EU) No 1022/2011 of 14 October 2011

  L 270

20

15.10.2011

►M23

COMMISSION IMPLEMENTING REGULATION (EU) No 1100/2011 of 31 October 2011

  L 285

10

1.11.2011

►M24

COMMISSION IMPLEMENTING REGULATION (EU) No 1134/2011 of 9 November 2011

  L 292

1

10.11.2011

►M25

COMMISSION IMPLEMENTING REGULATION (EU) No 1143/2011 of 10 November 2011

  L 293

26

11.11.2011

 M26

COMMISSION IMPLEMENTING REGULATION (EU) No 1278/2011 of 8 December 2011

  L 327

49

9.12.2011

►M27

COMMISSION IMPLEMENTING REGULATION (EU) No 87/2012 of 1 February 2012

  L 30

8

2.2.2012

►M28

COMMISSION IMPLEMENTING REGULATION (EU) No 127/2012 of 14 February 2012

  L 41

12

15.2.2012

►M29

COMMISSION IMPLEMENTING REGULATION (EU) No 287/2012 of 30 March 2012

  L 95

7

31.3.2012

►M30

COMMISSION IMPLEMENTING REGULATION (EU) No 359/2012 of 25 April 2012

  L 114

1

26.4.2012

►M31

COMMISSION IMPLEMENTING REGULATION (EU) No 369/2012 of 27 April 2012

  L 116

19

28.4.2012

►M32

COMMISSION IMPLEMENTING REGULATION (EU) No 571/2012 of 28 June 2012

  L 169

46

29.6.2012

►M33

COMMISSION IMPLEMENTING REGULATION (EU) No 582/2012 of 2 July 2012

  L 173

3

3.7.2012

►M34

COMMISSION IMPLEMENTING REGULATION (EU) No 589/2012 of 4 July 2012

  L 175

7

5.7.2012

►M35

COMMISSION IMPLEMENTING REGULATION (EU) No 595/2012 of 5 July 2012

  L 176

46

6.7.2012

►M36

COMMISSION IMPLEMENTING REGULATION (EU) No 597/2012 of 5 July 2012

  L 176

54

6.7.2012

►M37

COMMISSION IMPLEMENTING REGULATION (EU) No 608/2012 of 6 July 2012

  L 177

19

7.7.2012

►M38

COMMISSION IMPLEMENTING REGULATION (EU) No 637/2012 of 13 July 2012

  L 186

20

14.7.2012

►M39

COMMISSION IMPLEMENTING REGULATION (EU) No 735/2012 of 14 August 2012

  L 218

3

15.8.2012

►M40

COMMISSION IMPLEMENTING REGULATION (EU) No 746/2012 of 16 August 2012

  L 219

15

17.8.2012

►M41

COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2012 of 7 November 2012

  L 308

15

8.11.2012

►M42

COMMISSION IMPLEMENTING REGULATION (EU) No 1043/2012 of 8 November 2012

  L 310

24

9.11.2012

►M43

COMMISSION IMPLEMENTING REGULATION (EU) No 1197/2012 of 13 December 2012

  L 342

27

14.12.2012

►M44

COMMISSION IMPLEMENTING REGULATION (EU) No 1237/2012 of 19 December 2012

  L 350

55

20.12.2012

►M45

COMMISSION IMPLEMENTING REGULATION (EU) No 1238/2012 of 19 December 2012

  L 350

59

20.12.2012

►M46

COMMISSION IMPLEMENTING REGULATION (EU) No 17/2013 of 14 January 2013

  L 9

5

15.1.2013

►M47

COMMISSION IMPLEMENTING REGULATION (EU) No 22/2013 of 15 January 2013

  L 11

8

16.1.2013

►M48

COMMISSION IMPLEMENTING REGULATION (EU) No 175/2013 of 27 February 2013

  L 56

4

28.2.2013

►M49

COMMISSION IMPLEMENTING REGULATION (EU) No 187/2013 of 5 March 2013

  L 62

10

6.3.2013

►M50

COMMISSION IMPLEMENTING REGULATION (EU) No 188/2013 of 5 March 2013

  L 62

13

6.3.2013

►M51

COMMISSION IMPLEMENTING REGULATION (EU) No 190/2013 of 5 March 2013

  L 62

19

6.3.2013

►M52

COMMISSION IMPLEMENTING REGULATION (EU) No 200/2013 of 8 March 2013

  L 67

1

9.3.2013

►M53

COMMISSION IMPLEMENTING REGULATION (EU) No 201/2013 of 8 March 2013

  L 67

6

9.3.2013

►M54

COMMISSION IMPLEMENTING REGULATION (EU) No 350/2013 of 17 April 2013

  L 108

9

18.4.2013

►M55

COMMISSION IMPLEMENTING REGULATION (EU) No 355/2013 of 18 April 2013

  L 109

14

19.4.2013

►M56

COMMISSION IMPLEMENTING REGULATION (EU) No 356/2013 of 18 April 2013

  L 109

18

19.4.2013

►M57

COMMISSION IMPLEMENTING REGULATION (EU) No 365/2013 of 22 April 2013

  L 111

27

23.4.2013

►M58

COMMISSION IMPLEMENTING REGULATION (EU) No 366/2013 of 22 April 2013

  L 111

30

23.4.2013

►M59

COMMISSION IMPLEMENTING REGULATION (EU) No 367/2013 of 22 April 2013

  L 111

33

23.4.2013

►M60

COMMISSION IMPLEMENTING REGULATION (EU) No 368/2013 of 22 April 2013

  L 111

36

23.4.2013

►M61

COMMISSION IMPLEMENTING REGULATION (EU) No 369/2013 of 22 April 2013

  L 111

39

23.4.2013

►M62

COMMISSION IMPLEMENTING REGULATION (EU) No 373/2013 of 23 April 2013

  L 112

10

24.4.2013

►M63

COMMISSION IMPLEMENTING REGULATION (EU) No 375/2013 of 23 April 2013

  L 112

15

24.4.2013

►M64

COMMISSION IMPLEMENTING REGULATION (EU) No 378/2013 of 24 April 2013

  L 113

5

25.4.2013

 M65

COMMISSION IMPLEMENTING REGULATION (EU) No 485/2013 of 24 May 2013

  L 139

12

25.5.2013

►M66

COMMISSION IMPLEMENTING REGULATION (EU) No 532/2013 of 10 June 2013

  L 159

6

11.6.2013

 M67

COMMISSION IMPLEMENTING REGULATION (EU) No 533/2013 of 10 June 2013

  L 159

9

11.6.2013

►M68

COMMISSION IMPLEMENTING REGULATION (EU) No 546/2013 of 14 June 2013

  L 163

17

15.6.2013

►M69

COMMISSION IMPLEMENTING REGULATION (EU) No 568/2013 of 18 June 2013

  L 167

33

19.6.2013

►M70

COMMISSION IMPLEMENTING REGULATION (EU) No 570/2013 of 17 June 2013

  L 168

18

20.6.2013

 M71

COMMISSION IMPLEMENTING REGULATION (EU) No 762/2013 of 7 August 2013

  L 213

14

8.8.2013

►M72

COMMISSION IMPLEMENTING REGULATION (EU) No 767/2013 of 8 August 2013

  L 214

5

9.8.2013

►M73

COMMISSION IMPLEMENTING REGULATION (EU) No 781/2013 of 14 August 2013

  L 219

22

15.8.2013

►M74

COMMISSION IMPLEMENTING REGULATION (EU) No 790/2013 of 19 August 2013

  L 222

6

20.8.2013

►M75

COMMISSION IMPLEMENTING REGULATION (EU) No 798/2013 of 21 August 2013

  L 224

9

22.8.2013

►M76

COMMISSION IMPLEMENTING REGULATION (EU) No 802/2013 of 22 August 2013

  L 225

13

23.8.2013

►M77

COMMISSION IMPLEMENTING REGULATION (EU) No 826/2013 of 29 August 2013

  L 232

13

30.8.2013

►M78

COMMISSION IMPLEMENTING REGULATION (EU) No 827/2013 of 29 August 2013

  L 232

18

30.8.2013

►M79

COMMISSION IMPLEMENTING REGULATION (EU) No 828/2013 of 29 August 2013

  L 232

23

30.8.2013

►M80

COMMISSION IMPLEMENTING REGULATION (EU) No 829/2013 of 29 August 2013

  L 232

29

30.8.2013

►M81

COMMISSION IMPLEMENTING REGULATION (EU) No 832/2013 of 30 August 2013

  L 233

3

31.8.2013

►M82

COMMISSION IMPLEMENTING REGULATION (EU) No 833/2013 of 30 August 2013

  L 233

7

31.8.2013

►M83

COMMISSION IMPLEMENTING REGULATION (EU) No 1031/2013 of 24 October 2013

  L 283

17

25.10.2013

 M84

COMMISSION IMPLEMENTING REGULATION (EU) No 1089/2013 of 4 November 2013

  L 293

31

5.11.2013

►M85

COMMISSION IMPLEMENTING REGULATION (EU) No 1124/2013 of 8 November 2013

  L 299

34

9.11.2013

 M86

COMMISSION IMPLEMENTING REGULATION (EU) No 1136/2013 of 12 November 2013

  L 302

34

13.11.2013

►M87

COMMISSION IMPLEMENTING REGULATION (EU) No 1150/2013 of 14 November 2013

  L 305

13

15.11.2013

►M88

COMMISSION IMPLEMENTING REGULATION (EU) No 1165/2013 of 18 November 2013

  L 309

17

19.11.2013

►M89

COMMISSION IMPLEMENTING REGULATION (EU) No 1166/2013 of 18 November 2013

  L 309

22

19.11.2013

►M90

COMMISSION IMPLEMENTING REGULATION (EU) No 1175/2013 of 20 November 2013

  L 312

18

21.11.2013

►M91

COMMISSION IMPLEMENTING REGULATION (EU) No 1176/2013 of 20 November 2013

  L 312

23

21.11.2013

►M92

COMMISSION IMPLEMENTING REGULATION (EU) No 1177/2013 of 20 November 2013

  L 312

28

21.11.2013

 M93

COMMISSION IMPLEMENTING REGULATION (EU) No 1178/2013 of 20 November 2013

  L 312

33

21.11.2013

►M94

COMMISSION IMPLEMENTING REGULATION (EU) No 1187/2013 of 21 November 2013

  L 313

42

22.11.2013

►M95

COMMISSION IMPLEMENTING REGULATION (EU) No 1192/2013 of 22 November 2013

  L 314

6

23.11.2013

►M96

COMMISSION IMPLEMENTING REGULATION (EU) No 1195/2013 of 22 November 2013

  L 315

27

26.11.2013

►M97

COMMISSION IMPLEMENTING REGULATION (EU) No 1199/2013 of 25 November 2013

  L 315

69

26.11.2013

 M98

COMMISSION IMPLEMENTING REGULATION (EU) No 85/2014 of 30 January 2014

  L 28

34

31.1.2014

►M99

COMMISSION IMPLEMENTING REGULATION (EU) No 140/2014 of 13 February 2014

  L 44

35

14.2.2014

►M100

COMMISSION IMPLEMENTING REGULATION (EU) No 141/2014 of 13 February 2014

  L 44

40

14.2.2014

►M101

COMMISSION IMPLEMENTING REGULATION (EU) No 143/2014 of 14 February 2014

  L 45

1

15.2.2014

►M102

COMMISSION IMPLEMENTING REGULATION (EU) No 144/2014 of 14 February 2014

  L 45

7

15.2.2014

►M103

COMMISSION IMPLEMENTING REGULATION (EU) No 145/2014 of 14 February 2014

  L 45

12

15.2.2014

►M104

COMMISSION IMPLEMENTING REGULATION (EU) No 149/2014 of 17 February 2014

  L 46

3

18.2.2014

►M105

COMMISSION IMPLEMENTING REGULATION (EU) No 151/2014 of 18 February 2014

  L 48

1

19.2.2014

►M106

COMMISSION IMPLEMENTING REGULATION (EU) No 154/2014 of 19 February 2014

  L 50

7

20.2.2014

 M107

COMMISSION IMPLEMENTING REGULATION (EU) No 187/2014 of 26 February 2014

  L 57

24

27.2.2014

►M108

COMMISSION IMPLEMENTING REGULATION (EU) No 192/2014 of 27 February 2014

  L 59

20

28.2.2014

►M109

COMMISSION IMPLEMENTING REGULATION (EU) No 193/2014 of 27 February 2014

  L 59

25

28.2.2014

►M110

COMMISSION IMPLEMENTING REGULATION (EU) No 462/2014 of 5 May 2014

  L 134

28

7.5.2014

►M111

COMMISSION IMPLEMENTING REGULATION (EU) No 485/2014 of 12 May 2014

  L 138

65

13.5.2014

►M112

COMMISSION IMPLEMENTING REGULATION (EU) No 486/2014 of 12 May 2014

  L 138

70

13.5.2014

 M113

COMMISSION IMPLEMENTING REGULATION (EU) No 487/2014 of 12 May 2014

  L 138

72

13.5.2014

►M114

COMMISSION IMPLEMENTING REGULATION (EU) No 496/2014 of 14 May 2014

  L 143

1

15.5.2014

►M115

COMMISSION IMPLEMENTING REGULATION (EU) No 504/2014 of 15 May 2014

  L 145

28

16.5.2014

►M116

COMMISSION IMPLEMENTING REGULATION (EU) No 563/2014 of 23 May 2014

  L 156

5

24.5.2014

►M117

COMMISSION IMPLEMENTING REGULATION (EU) No 571/2014 of 26 May 2014

  L 157

96

27.5.2014

 M118

COMMISSION IMPLEMENTING REGULATION (EU) No 629/2014 of 12 June 2014

  L 174

33

13.6.2014

►M119

COMMISSION IMPLEMENTING REGULATION (EU) No 632/2014 of 13 May 2014

  L 175

1

14.6.2014

 M120

COMMISSION IMPLEMENTING REGULATION (EU) No 678/2014 of 19 June 2014

  L 180

11

20.6.2014

 M121

COMMISSION IMPLEMENTING REGULATION (EU) No 878/2014 of 12 August 2014

  L 240

18

13.8.2014

►M122

COMMISSION IMPLEMENTING REGULATION (EU) No 880/2014 of 12 August 2014

  L 240

22

13.8.2014

►M123

COMMISSION IMPLEMENTING REGULATION (EU) No 890/2014 of 14 August 2014

  L 243

42

15.8.2014

►M124

COMMISSION IMPLEMENTING REGULATION (EU) No 891/2014 of 14 August 2014

  L 243

47

15.8.2014

►M125

COMMISSION IMPLEMENTING REGULATION (EU) No 916/2014 of 22 August 2014

  L 251

16

23.8.2014

►M126

COMMISSION IMPLEMENTING REGULATION (EU) No 917/2014 of 22 August 2014

  L 251

19

23.8.2014

►M127

COMMISSION IMPLEMENTING REGULATION (EU) No 918/2014 of 22 August 2014

  L 251

24

23.8.2014

►M128

COMMISSION IMPLEMENTING REGULATION (EU) No 921/2014 of 25 August 2014

  L 252

3

26.8.2014

►M129

COMMISSION IMPLEMENTING REGULATION (EU) No 922/2014 of 25 August 2014

  L 252

6

26.8.2014

►M130

COMMISSION IMPLEMENTING REGULATION (EU) No 1316/2014 of 11 December 2014

  L 355

1

12.12.2014

►M131

COMMISSION IMPLEMENTING REGULATION (EU) No 1330/2014 of 15 December 2014

  L 359

85

16.12.2014

►M132

COMMISSION IMPLEMENTING REGULATION (EU) No 1334/2014 of 16 December 2014

  L 360

1

17.12.2014

►M133

COMMISSION IMPLEMENTING REGULATION (EU) 2015/51 of 14 January 2015

  L 9

22

15.1.2015

►M134

COMMISSION IMPLEMENTING REGULATION (EU) 2015/58 of 15 January 2015

  L 10

25

16.1.2015

 M135

COMMISSION IMPLEMENTING REGULATION (EU) 2015/232 of 13 February 2015

  L 39

7

14.2.2015

►M136

COMMISSION IMPLEMENTING REGULATION (EU) 2015/306 of 26 February 2015

  L 56

1

27.2.2015

►M137

COMMISSION IMPLEMENTING REGULATION (EU) 2015/307 of 26 February 2015

  L 56

6

27.2.2015

 M138

COMMISSION IMPLEMENTING REGULATION (EU) 2015/308 of 26 February 2015

  L 56

9

27.2.2015

►M139

COMMISSION IMPLEMENTING REGULATION (EU) 2015/404 of 11 March 2015

  L 67

6

12.3.2015

 M140

COMMISSION IMPLEMENTING REGULATION (EU) 2015/415 of 12 March 2015

  L 68

28

13.3.2015

 M141

COMMISSION IMPLEMENTING REGULATION (EU) 2015/418 of 12 March 2015

  L 68

36

13.3.2015

►M142

COMMISSION IMPLEMENTING REGULATION (EU) 2015/543 of 1 April 2015

  L 90

1

2.4.2015

►M143

COMMISSION IMPLEMENTING REGULATION (EU) 2015/553 of 7 April 2015

  L 92

86

8.4.2015

►M144

COMMISSION IMPLEMENTING REGULATION (EU) 2015/762 of 12 May 2015

  L 120

6

13.5.2015

►M145

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1106 of 8 July 2015

  L 181

70

9.7.2015

►M146

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1107 of 8 July 2015

  L 181

72

9.7.2015

►M147

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1108 of 8 July 2015

  L 181

75

9.7.2015

►M148

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1115 of 9 July 2015

  L 182

22

10.7.2015

►M149

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1116 of 9 July 2015

  L 182

26

10.7.2015

►M150

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1154 of 14 July 2015

  L 187

18

15.7.2015

►M151

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1165 of 15 July 2015

  L 188

30

16.7.2015

►M152

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1166 of 15 July 2015

  L 188

34

16.7.2015

►M153

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1176 of 17 July 2015

  L 192

1

18.7.2015

►M154

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1192 of 20 July 2015

  L 193

124

21.7.2015

►M155

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1201 of 22 July 2015

  L 195

37

23.7.2015

►M156

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1295 of 27 July 2015

  L 199

8

29.7.2015

►M157

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1392 of 13 August 2015

  L 215

34

14.8.2015

►M158

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1396 of 14 August 2015

  L 216

1

15.8.2015

►M159

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1397 of 14 August 2015

  L 216

3

15.8.2015

 M160

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1885 of 20 October 2015

  L 276

48

21.10.2015

►M161

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2033 of 13 November 2015

  L 298

8

14.11.2015

►M162

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2047 of 16 November 2015

  L 300

8

17.11.2015

►M163

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2069 of 17 November 2015

  L 301

42

18.11.2015

►M164

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2084 of 18 November 2015

  L 302

89

19.11.2015

►M165

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2085 of 18 November 2015

  L 302

93

19.11.2015

►M166

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2105 of 20 November 2015

  L 305

31

21.11.2015

►M167

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2198 of 27 November 2015

  L 313

35

28.11.2015

►M168

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2233 of 2 December 2015

  L 317

26

3.12.2015

►M169

COMMISSION IMPLEMENTING REGULATION (EU) 2016/139 of 2 February 2016

  L 27

7

3.2.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/146 of 4 February 2016

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7

5.2.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/147 of 4 February 2016

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12

5.2.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/177 of 10 February 2016

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1

11.2.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/182 of 11 February 2016

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40

12.2.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/370 of 15 March 2016

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7

16.3.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/389 of 17 March 2016

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77

18.3.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/548 of 8 April 2016

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1

9.4.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/549 of 8 April 2016

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4

9.4.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/560 of 11 April 2016

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23

12.4.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/636 of 22 April 2016

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22

23.4.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/638 of 22 April 2016

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28

23.4.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/864 of 31 May 2016

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32

1.6.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/871 of 1 June 2016

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4

2.6.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/872 of 1 June 2016

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7

2.6.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/950 of 15 June 2016

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3

16.6.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/951 of 15 June 2016

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6

16.6.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/952 of 15 June 2016

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10

16.6.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1056 of 29 June 2016

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52

30.6.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1313 of 1 August 2016

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1

2.8.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1414 of 24 August 2016

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16

25.8.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1423 of 25 August 2016

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20

26.8.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1424 of 25 August 2016

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25

26.8.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1425 of 25 August 2016

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30

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1426 of 25 August 2016

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34

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1429 of 26 August 2016

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1

27.8.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1978 of 11 November 2016

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23

12.11.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/2016 of 17 November 2016

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21

18.11.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/2035 of 21 November 2016

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7

22.11.2016

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/157 of 30 January 2017

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5

31.1.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/195 of 3 February 2017

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21

4.2.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/239 of 10 February 2017

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39

11.2.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/244 of 10 February 2017

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54

11.2.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/270 of 16 February 2017

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48

17.2.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/359 of 28 February 2017

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8

1.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/360 of 28 February 2017

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11

1.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/375 of 2 March 2017

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3

4.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/406 of 8 March 2017

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83

9.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/407 of 8 March 2017

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87

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/408 of 8 March 2017

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91

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/409 of 8 March 2017

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95

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/419 of 9 March 2017

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4

10.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/428 of 10 March 2017

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1

11.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/438 of 13 March 2017

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67

14.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/555 of 24 March 2017

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1

25.3.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/725 of 24 April 2017

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24

25.4.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/753 of 28 April 2017

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24

29.4.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/755 of 28 April 2017

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35

29.4.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/781 of 5 May 2017

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1

6.5.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/805 of 11 May 2017

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26

12.5.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/806 of 11 May 2017

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31

12.5.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/831 of 16 May 2017

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27

17.5.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/841 of 17 May 2017

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12

18.5.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/842 of 17 May 2017

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16

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/843 of 17 May 2017

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21

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/855 of 18 May 2017

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10

19.5.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/856 of 18 May 2017

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14

19.5.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1113 of 22 June 2017

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27

23.6.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1114 of 22 June 2017

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32

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1115 of 22 June 2017

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38

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1125 of 22 June 2017

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10

24.6.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1186 of 3 July 2017

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131

4.7.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1455 of 10 August 2017

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28

11.8.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1491 of 21 August 2017

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15

22.8.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1496 of 23 August 2017

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7

24.8.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1506 of 28 August 2017

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21

29.8.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1511 of 30 August 2017

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115

31.8.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1527 of 6 September 2017

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3

7.9.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1529 of 7 September 2017

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1

8.9.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1530 of 7 September 2017

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4

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1531 of 7 September 2017

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6

8.9.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2066 of 13 November 2017

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43

14.11.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2069 of 13 November 2017

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51

14.11.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2090 of 14 November 2017

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22

15.11.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2091 of 14 November 2017

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25

15.11.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2324 of 12 December 2017

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10

15.12.2017

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/84 of 19 January 2018

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8

20.1.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/112 of 24 January 2018

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3

25.1.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/113 of 24 January 2018

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7

25.1.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/184 of 7 February 2018

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10

8.2.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/185 of 7 February 2018

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13

8.2.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/291 of 26 February 2018

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30

27.2.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/309 of 1 March 2018

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16

2.3.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/524 of 28 March 2018

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4

4.4.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/660 of 26 April 2018

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122

30.4.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/670 of 30 April 2018

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1

3.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/679 of 3 May 2018

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18

4.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/690 of 7 May 2018

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3

8.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/691 of 7 May 2018

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6

8.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/692 of 7 May 2018

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9

8.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/710 of 14 May 2018

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31

15.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/755 of 23 May 2018

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4

24.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/783 of 29 May 2018

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31

30.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/784 of 29 May 2018

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35

30.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/785 of 29 May 2018

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40

30.5.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/917 of 27 June 2018

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13

28.6.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1019 of 18 July 2018

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14

19.7.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1043 of 24 July 2018

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9

25.7.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1060 of 26 July 2018

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3

27.7.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1061 of 26 July 2018

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8

27.7.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1075 of 27 July 2018

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36

31.7.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1260 of 20 September 2018

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30

21.9.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1262 of 20 September 2018

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62

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1264 of 20 September 2018

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71

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1265 of 20 September 2018

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77

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1266 of 20 September 2018

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81

21.9.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1278 of 21 September 2018

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4

24.9.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1295 of 26 September 2018

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7

27.9.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1495 of 8 October 2018

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1

9.10.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1500 of 9 October 2018

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1

10.10.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1501 of 9 October 2018

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4

10.10.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1532 of 12 October 2018

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10

15.10.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1796 of 20 November 2018

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15

21.11.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1865 of 28 November 2018

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6

29.11.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1913 of 6 December 2018

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13

7.12.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1914 of 6 December 2018

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17

7.12.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1915 of 6 December 2018

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20

7.12.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1916 of 6 December 2018

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24

7.12.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1917 of 6 December 2018

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27

7.12.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1981 of 13 December 2018

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16

14.12.2018

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/139 of 29 January 2019

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4

30.1.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/147 of 30 January 2019

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14

31.1.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/149 of 30 January 2019

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20

31.1.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/151 of 30 January 2019

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26

31.1.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/158 of 31 January 2019

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21

1.2.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/168 of 31 January 2019

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1

5.2.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/291 of 19 February 2019

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17

20.2.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/324 of 25 February 2019

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1

26.2.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/337 of 27 February 2019

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12

28.2.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/344 of 28 February 2019

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7

1.3.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/481 of 22 March 2019

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19

25.3.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/676 of 29 April 2019

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12

30.4.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/677 of 29 April 2019

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15

30.4.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/706 of 7 May 2019

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11

8.5.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/707 of 7 May 2019

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16

8.5.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/716 of 30 April 2019

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39

10.5.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/717 of 8 May 2019

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44

10.5.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/989 of 17 June 2019

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11

18.6.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1085 of 25 June 2019

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110

26.6.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1090 of 26 June 2019

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39

27.6.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1100 of 27 June 2019

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17

28.6.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1101 of 27 June 2019

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20

28.6.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1137 of 3 July 2019

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3

4.7.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1138 of 3 July 2019

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8

4.7.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1589 of 26 September 2019

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24

27.9.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1605 of 27 September 2019

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49

30.9.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1606 of 27 September 2019

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53

30.9.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1675 of 4 October 2019

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6

8.10.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/1690 of 9 October 2019

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2

10.10.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/2094 of 29 November 2019

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102

9.12.2019

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/17 of 10 January 2020

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11

13.1.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/18 of 10 January 2020

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14

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/23 of 13 January 2020

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8

14.1.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/421 of 18 March 2020

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7

20.3.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/616 of 5 May 2020

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1

6.5.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/617 of 5 May 2020

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6

6.5.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/642 of 12 May 2020

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134

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/646 of 13 May 2020

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3

14.5.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/653 of 14 May 2020

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1

15.5.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/869 of 24 June 2020

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7

25.6.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/892 of 29 June 2020

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5

30.6.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/968 of 3 July 2020

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7

6.7.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1003 of 9 July 2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1004 of 9 July 2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1018 of 13 July 2020

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9

14.7.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1160 of 5 August 2020

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29

6.8.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1246 of 2 September 2020

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18

3.9.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1263 of 10 September 2020

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1

11.9.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1276 of 11 September 2020

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32

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1280 of 14 September 2020

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4

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1293 of 15 September 2020

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24

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1498 of 15 October 2020

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5

16.10.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1511 of 16 October 2020

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18

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1643 of 5 November 2020

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18

6.11.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/2007 of 8 December 2020

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10

9.12.2020

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/2087 of 14 December 2020

  L 423

50

15.12.2020

►M345

COMMISSION IMPLEMENTING REGULATION (EU) 2020/2101 of 15 December 2020

  L 425

79

16.12.2020

►M346

COMMISSION IMPLEMENTING REGULATION (EU) 2020/2104 of 15 December 2020

  L 425

93

16.12.2020

►M347

COMMISSION IMPLEMENTING REGULATION (EU) 2020/2105 of 15 December 2020

  L 425

96

16.12.2020

►M348

COMMISSION IMPLEMENTING REGULATION (EU) 2021/52 of 22 January 2021

  L 23

13

25.1.2021

►M349

COMMISSION IMPLEMENTING REGULATION (EU) 2021/81 of 27 January 2021

  L 29

12

28.1.2021

►M350

COMMISSION IMPLEMENTING REGULATION (EU) 2021/129 of 3 February 2021

  L 40

11

4.2.2021

►M351

COMMISSION IMPLEMENTING REGULATION (EU) 2021/134 of 4 February 2021

  L 42

4

5.2.2021

►M352

COMMISSION IMPLEMENTING REGULATION (EU) 2021/413 of 8 March 2021

  L 81

32

9.3.2021

►M353

COMMISSION IMPLEMENTING REGULATION (EU) 2021/427 of 10 March 2021

  L 84

21

11.3.2021


Corrected by:

►C1

Corrigendum, OJ L 026, 28.1.2012, p.  38 (540/2011)

►C2

Corrigendum, OJ L 235, 4.9.2013, p.  12 (200/2013)

►C3

Corrigendum, OJ L 277, 22.10.2015, p.  60 (140/2014)

►C4

Corrigendum, OJ L 002, 5.1.2018, p.  15 (2017/842)




▼B

COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011

of 25 May 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

(Text with EEA relevance)



▼M1

Article 1

The active substances, as set out in Part A of the Annex, shall be deemed to have been approved under Regulation (EC) No 1107/2009.

▼M166

The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation. The low-risk active substances approved under Regulation (EC) No 1107/2009 are as set out in Part D of the Annex to this Regulation. The candidates for substitution approved under Regulation (EC) No 1107/2009 are as set out in Part E of the Annex to this Regulation.

▼B

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 14 June 2011.

This Regulation shall be binding in its entirety and directly applicable in all Member States.




▼M110

ANNEX ACTIVE SUBSTANCES

▼M1

PART A

Active substances deemed to have been approved under Regulation (EC) No 1107/2009

General provisions applying to all substances listed in this Part:

▼B

— 
for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;
— 
Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.



Number

Common name, identification numbers

IUPAC name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

▼M6 —————

▼M4 —————

▼M18 —————

▼M13 —————

▼M5 —————

▼M8 —————

▼M169 —————

▼M3 —————

▼M181 —————

▼M162 —————

▼M253 —————

▼M170 —————

▼M155 —————

▼M182 —————

▼M280 —————

▼M148 —————

▼M198 —————

▼M136 —————

▼M233 —————

▼M175 —————

▼M22

21

Cyclanilide

CAS No 113136-77-9

CIPAC No 586

Not available

960  g/kg

1 November 2001

31 October 2011

Only uses as a plant growth regulator may be authorised.

The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

▼M152 —————

▼M279 —————

▼M173 —————

▼M244 —————

▼M191 —————

▼M161 —————

▼M183 —————

▼M193 —————

▼M171 —————

▼M205 —————

▼M150 —————

▼M24

33

Cinidon-ethyl

CAS No 142891-20-1

CIPAC No 598

(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate

940  g/kg

1 October 2002

30 September 2012

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions,

— should pay particular attention to the protection of aquatic organisms.

Conditions of authorisation must include risk mitigation measures, where appropriate.

▼M215 —————

▼B

35

Famoxadone

CAS No 131807-57-3

CIPAC No 594

3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione

960  g/kg

1 October 2002

►M328  30 June 2021 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms;

— Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

— Member States should pay particular attention to the protection of operators.

▼M159 —————

▼M324 —————

▼M190 —————

▼B

39

Flumioxazine

CAS No 103361-09-7

CICAP No 578

N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide

960  g/kg

1 January 2003

►M328  30 June 2021 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States:

— must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate.

40

Deltamethrin

CAS No 52918-63-5

CIPAC No 333

(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate

980  g/kg

1 November 2003

►M341  31 October 2021 ◄

Only uses as insecticide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States:

— must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures,

— should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels,

— must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.

▼M239 —————

▼M265 —————

▼B

43

Ethoxysulfuron

CAS No 126801-58-9

CIPAC No 591

3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea

950  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

Member States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate.

▼M323 —————

▼B

45

Oxadiargyl

CAS No 39807-15-3

CIPAC No 604

5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one

980  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate.

46

Cyazofamid

CAS No 120116-88-3

CIPAC No 653

4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide

935  g/kg

1 July 2003

►M328  31 July 2021 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms;

— Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions.

Risk mitigation measures or use restrictions should be applied where appropriate.

▼M232 —————

▼M329 —————

▼B

49

Cyfluthrin

CAS No 68359-37-5 (unstated stereochemistry)

CIPAC No 385

(RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate

920  g/kg

1 January 2004

31 December 2013

Only use as insecticide may be authorised

Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops.

For the implementation of the uniform principles, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.

▼M243 —————

▼M201 —————

▼M234 —————

▼M227 —————

▼M251 —————

▼M260 —————

▼B

56

Mecoprop

CAS No 7085-19-0

CIPAC No 51

(RS)-2-(4-chloro-o-tolyloxy)-propionic acid

930  g/kg

1 June 2004

31 May 2014

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate.

57

Mecoprop-P

CAS No 16484-77-8

CIPAC No 475

(R)-2-(4-chloro-o-tolyloxy)-propionic acid

860  g/kg

1 June 2004

►M348  31 January 2022 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

▼M282 —————

▼M267 —————

▼M268 —————

▼M214 —————

▼M266 —————

▼M305 —————

▼M287 —————

▼B

65

Flufenacet

CAS No 142459-58-3

CIPAC No 588

4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide

950  g/kg

1 January 2004

►M341  31 October 2021 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

— should pay particular attention to the protection of algae and aquatic plants,

— should pay particular attention to the protection of operators.

Risk mitigation measures should be applied where appropriate.

▼M207 —————

▼M311 —————

▼M231 —————

▼B

69

Fosthiazate

CAS No 98886-44-3

CIPAC No 585

(RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate

930  g/kg

1 January 2004

►M341  31 October 2021 ◄

Only uses as insecticide or nematicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States

— should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions;

— should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season;

— should pay particular attention to the protection of non-target soil organisms.

Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

▼M259 —————

▼M222 —————

▼B

72

Molinate

CAS No 2212-67-1

CIPAC No 235

S-ethyl azepane-1-carbothioate;

S-ethyl perhydroazepine-1-carbothioate;

S-ethyl perhydroazepine-1-thiocarboxilate

950  g/kg

1 August 2004

31 July 2014

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on molinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States should pay particular attention to the possibility of short-range transport of the active substance in air.

▼M278 —————

▼B

74

Ziram

CAS No 137-30-4

CIPAC No 31

Zinc bis (dimethyldithiocarbamate)

950 g/kg (FAO-specification)

Arsenic: maximum 250 mg/kg

Water: maximum 1,5 %

1 August 2004

►M322  30 April 2021 ◄

Only uses as fungicide or as repellent may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:

— Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate,

— Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels.

▼M216 —————

▼M228 —————

▼M258 —————

▼M306 —————

▼M226 —————

▼M218 —————

▼B

81

Pyraclostrobin

CAS No 175013-18-0

CIPAC No 657

methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate

975 g/kg

The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.

1 June 2004

►M348  31 January 2022 ◄

Only uses as fungicide or plant growth regulator may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States:

— should pay particular attention to the protection of aquatic organisms, especially fish,

— should pay particular attention to the protection of terrestrial arthropods and earthworms.

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

▼M284 —————

▼M317 —————

▼M338 —————

▼M337 —————

▼M309 —————

▼B

87

Ioxynil

CAS No 13684-83-4

CIPAC No 86

4- hydroxy- 3,5- di-iodobenzonitrile

960  g/kg

1 March 2005

28 February 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

88

Phenmedipham

CAS No 13684-63-4

CIPAC No 77

methyl 3-(3-methylcarbaniloyloxy)carbanilate;

3-methoxycarbonylaminophenyl 3′-methylcarbanilate

Min. 970 g/kg

1 March 2005

►M328  31 July 2021 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

89

Pseudomonas chlororaphis

Strain: MA 342

CIPAC No 574

Not applicable

The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l).

1 October 2004

►M322  30 April 2021 ◄

Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised.

When granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

In this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate.

90

Mepanipyrim

CAS No 110235-47-7

CIPAC No 611

N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline

960  g/kg

1 October 2004

►M322  30 April 2021 ◄

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.

▼M247 —————

▼M321 —————

▼M269 —————

▼B

94

Imazosulfuron

CAS No 122548-33-8

CIPAC No 590

1-(2-chloroimidazo[1,2-α]pyridin-3-ylsul-phonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea

≥ 980 g/kg

1 April 2005

►M43  31. July 2017 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic and terrestrial non-target plants. Risk mitigation measures should be applied where appropriate.

▼M246 —————

▼M293 —————

▼B

97

S-metolachlor

CAS No 87392-12-9

(S-isomer)

178961-20-1 (R-isomer)

CIPAC No 607

Mixture of:

(aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %)

and:

(aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %)

≥ 960 g/kg

1 April 2005

►M328  31 July 2021 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

In this overall assessment Member States:

— should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— should pay particular attention to the protection of aquatic plants.

Risk mitigation measures should be applied where appropriate.

▼M292 —————

▼M347 —————

▼B

100

Tepraloxydim

CAS No 149979-41-9

CIPAC No 608

(EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one

≥ 920 g/kg

1 June 2005

►M134  31. May 2015 ◄

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account.

In this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods.

Risk mitigation measures should be applied where appropriate.

▼M301 —————

▼B

102

Chlorotoluron (unstated stereochemistry)

CAS No 15545-48-9

CIPAC No 217

3-(3-chloro-p-tolyl)-1,1-dimethylurea

975  g/kg

1 March 2006

►M341  31 October 2021 ◄

PART A

Only uses as herbicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

103

Cypermethrin

CAS No 52315-07-8

CIPAC No 332

(RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate

(4 isomer pairs: cis-1, cis-2, trans-3, trans-4)

900  g/kg

1 March 2006

►M341  31 October 2021 ◄

PART A

Only uses as insecticide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate

104

Daminozide

CAS No 1596-84-5

CIPAC No 330

N-dimethylaminosuccinamic acid

990 g/kg

Impurities:

— N-nitrosodimethylamine: not more than 2,0 mg/kg

— 1,1-dimethylhydrazide: not more than 30 mg/kg

1 March 2006

►M341  31 October 2021 ◄

PART A

Only uses as growth regulator in non-edible crops may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate

▼M340 —————

▼M283 —————

▼B

107

MCPA

CAS No 94-74-6

CIPAC No 2

4-chloro-o-tolyloxyacetic acid

≥ 930 g/kg

1 May 2006

►M341  31 October 2021 ◄

PART A

Only uses as herbicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account

Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones

108

MCPB

CAS No 94-81-5

CIPAC No 50

4-(4-chloro-o-tolyloxy)butyric acid

≥ 920 g/kg

1 May 2006

►M341  31 October 2021 ◄

PART A

Only uses as herbicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account

Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones

109

Bifenazate

CAS No 149877-41-8

CIPAC No 736

Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate

≥ 950 g/kg

1 December 2005

►M328  31 July 2021 ◄

PART A

Only uses as acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

110

Milbemectin

Milbemectin is a mixture of M.A3 and M.A4

CAS No

M.A3: 51596-10-2

M.A4: 51596-11-3

CIPAC No 660

M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one

M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one

≥ 950 g/kg

1 December 2005

►M328  31 July 2021 ◄

PART A

Only uses as acaricide or insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

▼M320 —————

▼M319 —————

▼B

113

Maneb

CAS No 12427-38-2

CIPAC No 61

manganese ethylenebis (dithiocarbamate) (polymeric)

≥ 860 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content.

1 July 2006

►M197  31 January 2017 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity.

They shall ensure that the notifiers at whose request maneb has been included in this Annex provide such studies to the Commission within two years from the approval.

▼M344 —————

▼B

115

Metiram

CAS No 9006-42-2

CIPAC No 478

Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)]

≥ 840 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content.

1 July 2006

►M348  31 January 2022 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval.

116

Oxamyl

CAS No 23135-22-0

CIPAC No 342

N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide

970  g/kg

1 August 2006

►M348  31 January 2022 ◄

PART A

Only uses as nematicide and insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment,

— Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations.

Conditions of authorisation should include risk mitigation measures, where appropriate.

— Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval.

▼M307 —————

▼M255 —————

▼B

119

Indoxacarb

CAS No 173584-44-6

CIPAC No 612

methyl (S)-N-[7-chloro-2,3,4a,5-tetrahydro-4a-(methoxycarbonyl)indeno[1,2-e][1,3,4]oxadiazin-2-ylcarbonyl]-4′-(trifluoromethoxy)carbanilate

TC (Technical Material): ≥ 628 g/kg indoxacarb

1 April 2006

►M341  31 October 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on indoxacarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

In this overall assessment Member States must pay particular attention to the protection of aquatic organisms.

Conditions of use should include risk mitigation measures, where appropriate.

120

Warfarin

CAS No 81-81-2

CIPAC No 70

(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin

≥ 990 g/kg

1 October 2006

30 September 2013

PART A

Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals.

Risk mitigation measures should be applied where appropriate.

121

Clothianidin

CAS No 210880-92-5

CIPAC No 738

(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

≥ 960 g/kg

1 August 2006

►M245  31 January 2019 ◄

►M262

 

PART A

Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 and the conclusions of the revised addendum of the review report on clothianidin as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the risk to groundwater;

— the risk to bees and bumble bees released for pollination in permanent greenhouses;

— the exposure of bees via the consumption of contaminated water from the permanent greenhouses.

Member States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised.

Conditions of use shall include risk mitigation measures, where appropriate.

 ◄

▼M272 —————

▼B

123

Clodinafop

CAS No 114420-56-3

CIPAC No 683

(R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid

≥ 950 g/kg (expressed as clodinafop-propargyl)

1 February 2007

►M322  30 April 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

124

Pirimicarb

CAS No 23103-98-2

CIPAC No 231

2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate

≥ 950 g/kg

1 February 2007

►M322  30 April 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

Member States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment.

Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the approval.

125

Rimsulfuron

CAS No 122931-48-0 (rimsulfuron)

CIPAC No 716

1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea

≥ 960 g/kg (expressed as rimsulfuron)

1 February 2007

►M322  30 April 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.

▼M310 —————

▼B

127

Triticonazole

CAS No 131983-72-7

CIPAC No 652

(±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

≥ 950 g/kg

1 February 2007

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States:

— must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate,

— must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones,

— must pay particular attention to the protection of granivorous birds (long term risk).

Conditions of authorisation should include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval.

128

Dimoxystrobin

CAS No 149961-52-4

CIPAC No 739

(E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide

≥ 980 g/kg

1 October 2006

►M348  31 January 2022 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

In this overall assessment Member States

— must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions;

— must pay particular attention to the protection of aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of

— a refined risk assessment for birds and mammals considering the formulated active substance;

— a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage.

They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

129

Clopyralid

CAS No 1702-17-6

CIPAC No 455

3,6-dichloropyridine-2-carboxylic acid

≥ 950 g/kg

1 May 2007

►M322  30 April 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing clopyralid for uses other than spring applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the results on animal metabolism. They shall ensure that the notifiers at whose request clopyralid has been included in this Annex provide such studies to the Commission within two years from the approval.

130

Cyprodinil

CAS No 121522-61-2

CIPAC No 511

(4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine

≥ 980 g/kg

1 May 2007

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval.

131

Fosetyl

CAS No 15845-66-6

CIPAC No 384

Ethyl hydrogen phosphonate

≥ 960 g/kg (expressed as fosetyl-Al)

1 May 2007

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods.

Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval.

132

Trinexapac

CAS No 104273-73-6

CIPAC No 732

4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid

≥ 940 g/kg (expressed as trinexapac-ethyl)

1 May 2007

►M322  30 April 2021 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds and mammals.

Conditions of authorisation should include risk mitigation measures, where appropriate.

133

Dichlorprop-P

CAS No 15165-67-0

CIPAC No 476

(R)-2-(2,4-dichlorophenoxy) propanoic acid

≥ 900 g/kg

1 June 2007

►M322  30 April 2021 ◄

►M89  
PART A
Only uses as herbicide may be authorised.
As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.
Use on grassland shall not be authorised.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.
In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.
Conditions of authorisation shall include risk mitigation measures, where appropriate.  ◄

134

Metconazole

CAS No 125116-23-6 (unstated stereo-chemistry)

CIPAC No 706

(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol

≥ 940 g/kg

(sum of cis-and trans-isomers)

1 June 2007

►M322  30 April 2021 ◄

PART A

Only uses as fungicide and plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.

In this overall assessment:

— Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate,

— Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.

135

Pyrimethanil

CAS No 53112-28-0

CIPAC No not allocated

N-(4,6-dimethylpyrimidin-2-yl) aniline

≥ 975 g/kg

(the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material)

1 June 2007

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones,

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval.

136

Triclopyr

CAS No 055335-06-3

CIPAC No 376

3,5,6-trichloro-2-pyridyloxyacetic acid

≥ 960 g/kg

(as Triclopyr butoxyethyl ester)

1 June 2007

►M322  30 April 2021 ◄

►M137

 

PART A

Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account.

In this overall assessment Member States:

— shall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate,

— shall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate.

 ◄

137

Metrafenone

CAS No 220899-03-6

CIPAC No 752

3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone

≥ 940 g/kg

1 February 2007

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

138

Bacillus subtilis

(Cohn 1872)

Strain QST 713, identical with strain AQ 713

Culture collection No: NRRL B -21661

CIPAC No not allocated

Not applicable

 

1 February 2007

►M322  30 April 2021 ◄

►M158  
PART A
Only uses as fungicide and bactericide may be authorised.  ◄
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

139

Spinosad

CAS No 131929-60-7 (Spinosyn A)

131929-63-0 (Spinosyn D)

CIPAC No 636

Spinosyn A:

(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

Spinosyn D:

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D

≥ 850 g/kg

1 February 2007

►M322  30 April 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

In this overall assessment Member States

— must pay particular attention to the protection of aquatic organisms;

— must pay particular attention to the risk to earthworms when the substance is used in glasshouses.

Conditions of use shall include risk mitigation measures, where appropriate.

140

Thiamethoxam

CAS No 153719-23-4

CIPAC No 637

(E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine

≥ 980 g/kg

1 February 2007

►M252  30 April 2019 ◄

►M263

 

PART A

Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 and the conclusions of the revised addendum of the review report on thiamethoxam as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the risk to groundwater;

— the risk to aquatic organisms;

— the risk to bees and bumble bees released for pollination in permanent greenhouses;

— the exposure of bees via the consumption of contaminated water from the permanent greenhouses.

Member States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised.

Conditions of use shall include risk mitigation measures, where appropriate.

 ◄

▼M335 —————

▼B

142

Ethephon

CAS No 16672-87-0

CIPAC No 373

2-chloroethyl-phosphonic acid

≥ 910 g/kg (technical material — TC)

The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material.

1 August 2007

►M328  31 July 2021 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

143

Flusilazole (2)

CAS No 85509-19-9

CIPAC No 435

Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane

925  g/kg

1 January 2007

30 June 2008 (2)

PART A

Only uses as fungicide on the following crops may be authorised:

— cereals other than rice (2),

— maize (2),

— rape seed (2),

— sugar beet (2),

at rates not exceeding 200 g active substance per hectare per application.

The following uses must not be authorised:

— air application,

— knapsack and hand-held applications, neither by amateur nor by professional users,

— home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

— aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,

— birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,

— operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account.

Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained.

Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.

▼M2

144

Carbendazim

CAS No 10605-21-7

CIPAC No 263

Methyl benzimidazol-2-ylcarbamate

≥ 980 g/kg

Relevant impurities

2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg

2,3-diaminophenazine (DAP): not more than 0,003 g/kg

1 June 2011

30 November 2014

PART A

Only uses as fungicide on the following crops may be authorised:

— cereals

— rape seed

— sugar and fodder beet

— maize

at rates not exceeding

— 0,25 kg active substance per hectare per application for cereals and rape seed;

— 0,075 kg active substance per hectare per application for sugar and fodder beet

— 0,1 kg active substance per hectare per application for maize.

The following uses must not be authorised:

— air application;

— knapsack and handheld applications neither by amateur nor by professional users;

— home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

— aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices;

— earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance;

— birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary;

— operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbendazim, and in particular Appendices I and II thereof, shall be taken into account.

The Member States concerned shall request that the applicant provides the following to the Commission:

— by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197;

— by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 ‘Further information’, pp. 155 – 157);

— by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.

▼B

145

Captan

CAS No 133-06-02

CIPAC No 40

N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide

≥ 910 g/kg

Impurities:

Perchloromethylmercaptan (R005406): not more than 5 g/kg

Folpet: not more than 10 g/kg

Carbon tetrachloride not more than 0,1 g/Kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

— the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

— the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;

— the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval.

146

Folpet

CAS No 133-07-3

CIPAC No 75

N-(trichloromethylthio) phthalimide

≥ 940 g/kg

Impurities:

Perchloromethylmercaptan (R005406): not more than 3,5 g/kg

Carbon tetrachloride not more than 4 g/kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

— the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

— the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval.

147

Formetanate

CAS No 23422-53-9

CIPAC No 697

3-dimethylaminomethyleneaminophenyl methylcarbamate

≥ 910 g/kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

— must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval.

▼M315 —————

▼M308 —————

▼B

150

Dimethomorph

CAS No 110488-70-5

CIPAC No 483

(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine

≥ 965 g/kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

— to the protection of birds, mammals and aquatic organisms.

Conditions of authorisation should include risk mitigation measures, where appropriate.

151

Glufosinate

CAS No 77182-82-2

CIPAC No 437.007

ammonium(DL)-homoalanin-4-yl(methyl)phosphinate

950  g/kg

1 October 2007

►M139  31. July 2018 ◄

►M57  
PART A
Only uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year.
PART B
In assessing applications to authorise plant protection products containing glufosinate, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006, shall be taken into account. In this overall assessment Member States shall pay particular attention to:
(a)  the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate;
(b)  the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions;
(c)  the protection of mammals, non-target arthropods and non-target plants.
Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.  ◄

152

Metribuzin

CAS No 21087-64-9

CIPAC No 283

4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one

≥ 910 g/kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval.

153

Phosmet

CAS No 732-11-6

CIPAC No 318

O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide

≥ 950 g/kg

Impurities:

— phosmet oxon: not more than 0,8 g/kg

— iso phosmet: not more than 0,4 g/kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water,

— must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval.

154

Propamocarb

CAS No 24579-73-5

CIPAC No 399

Propyl 3-(dimethylamino) propylcarbamate

≥ 920 g/kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate;

— the transfer of soil residues for rotating or succeeding crops;

— the protection of surface and groundwater in vulnerable zones;

— the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

▼M298 —————

▼B

156

Pirimiphos-methyl

CAS No 29232-93-7

CIPAC No 239

O-2-diethylamino-6-methylpyrimidin-4-yl

O,O-dimethylphosphorothioate

> 880 g/kg

1 October 2007

►M328  31 July 2021 ◄

PART A

Only uses as insecticide for post harvest storage can be authorised.

Hand-held applications shall not be authorised.

PART B

In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure;

— the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

157

Fipronil

CAS No 120068-37-3

CIPAC No 581

(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile

≥ 950 g/kg

1 October 2007

►M197  30 September 2017 ◄

►M73  
PART A
Only uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a)  the packaging of the marketed products to avoid the generation of photodegradation products of concern;
(b)  the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;
(c)  the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.
Member States shall also ensure that:
(a)  the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised;
(b)  adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission;
(c)  the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation;
(d)  monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.
Conditions of use shall include risk mitigation measures, where appropriate.
The notifier shall submit confirmatory information as regards:
(a)  the risk to pollinators other than honey bees;
(b)  the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites;
(c)  the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift;
(d)  the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew;
(e)  the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development, and the risk to bee brood;
(f)  the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950).
The notifier shall submit that information to the Commission, the Member States and the Authority by 30 March 2015.  ◄

158

Beflubutamid

CAS No 113614-08-7

CIPAC No 662

(RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide

≥ 970 g/kg

1 December 2007

►M328  31 July 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.

In this overall assessment Member States:

— must pay particular attention to the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

159

Spodoptera exigua nuclear polyhedrosis virus

CIPAC No

Not allocated

Not applicable

 

1 December 2007

30 November 2017

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.

160

Prosulfocarb

CAS No 52888-80-9

CIPAC No 539

S-benzyl dipropyl(thiocarbamat)

970  g/kg

1 November 2008

►M341  31 October 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone,

— the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone.

161

Fludioxonil

CAS No 131341-86-1

CIPAC No 522

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

950  g/kg

1 November 2008

►M341  31 October 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and:

— must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones,

— must pay particular attention to the protection of fish and aquatic invertebrates.

Conditions of authorisation should include risk mitigation measures, where appropriate.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

162

Clomazone

CAS No 81777-89-1

CIPAC No 509

2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one

960  g/kg

1 November 2008

►M341  31 October 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones.

163

Benthiavalicarb

CAS No 413615-35-7

CIPAC No 744

[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid

≥ 910 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg

bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg

1 August 2008

►M328  31 July 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety,

— the protection of non-target arthropods.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

164

Boscalid

CAS No 188425-85-6

CIPAC No 673

2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide

≥ 960 g/kg

1 August 2008

►M328  31 July 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention

— to the operator safety,

— to the long term risk to birds and soil organisms,

— to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

▼M302 —————

▼B

166

Fluoxastrobin

CAS No 361377-29-9

CIPAC No 746

(E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime

≥ 940 g/kg

1 August 2008

►M328  31 July 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield,

— the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

— the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate,

— the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

— data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures,

— data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff.

They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

167

Paecilomyces lilacinus (Thom)

Samson 1974 strain 251 (AGAL: No 89/030550)

CIPAC No 753

Not applicable

 

1 August 2008

►M328  31 July 2021 ◄

PART A

Only uses as nematicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers),

— the protection of leaf dwelling non-target arthropods.

Conditions of use shall include risk mitigation measures, where appropriate.

168

Prothioconazole

CAS No 178928-70-6

CIPAC No 745

(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione

≥ 970 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

— Toluene: < 5 g/kg

— Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)

1 August 2008

►M328  31 July 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety in spray applications. Conditions of use shall include adequate protective measures,

— the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

— the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

— information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin,

— a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds,

— information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment.

They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval.

169

Amidosulfuron

CAS No 120923-37-7

CIPAC No 515

3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea

or

1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea

≥ 970 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of aquatic plants.

In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

170

Nicosulfuron

CAS No 111991-09-4

CIPAC No 709

2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide

or

1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea

≥ 910 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions,

— the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones,

— the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone,

— the protection of groundwater and surface water under vulnerable soil and climatic conditions.

171

Clofentezine

CAS No 74115-24-5

CIPAC No 418

3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine

≥ 980 g/kg (dry material)

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;

— the potential for long range transport via air;

— the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013.

The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012.

▼M23

172

Dicamba

CAS No 1918-00-9

CIPAC No 85

3,6-dichloro-2-methoxybenzoic acid

≥ 850 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of non-target plants.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  the identification and quantification of a group of soil transformation products formed in a soil incubation study;

(b)  the potential for long range transport through the atmosphere.

The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013.

173

Difenoconazole

CAS No 119446-68-3

CIPAC No 687

3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether

≥ 940g/kg

Toluene maximum content: 5 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  further data on the specification of the technical material;

(b)  residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin;

(c)  the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (16);

(d)  the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.

The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance.

▼B

174

Diflubenzuron

CAS No 35367-38-5

CIPAC No 339

1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea

≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline

1 January 2009

►M313  31 December 2020 ◄

PART A

►M224  Only uses as insecticide in non-edible crops may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the protection of aquatic organisms, terrestrial organisms and non-target arthropods including bees;

— the potential unintended exposure of food and feed crops to diflubenzuron from uses on non-edible crops (e.g. through spray drift);

— the protection of workers, residents and bystanders.

Member States shall ensure that crops treated with diflubenzuron do not enter the food and feed chain.

Conditions of use shall include adequate risk mitigation measures, where appropriate. ◄

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as finalised inthe Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the protection of aquatic organisms;

— the protection of terrestrial organisms;

— the protection of non-target arthropods including bees.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further studies to address the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.

▼M23

175

Imazaquin

CAS No 81335-37-7

CIPAC No 699

2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid

≥ 960 g/kg (racemic mixture)

1 January 2009

31 December 2018

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account

The notifier shall submit confirmatory information as regards:

(a)  further data on the specification of the technical material;

(b)  the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment.

The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012 and the information set out in point (b) within 2 years from the adoption of specific guidance.

▼B

176

Lenacil

CAS No 2164-08-1

CIPAC No 163

3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione

≥ 975 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies;

— the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.

177

Oxadiazon

CAS No 19666-30-9

CIPAC No 213

5-tert-butyl-3-(2,4-dichloro-5-isopropoxyphenyl)-1,3,4-oxadiazol-2(3H)-one

≥ 940 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

— the potential for ground water contamination by the metabolite AE0608022 where the active substance is applied in situations for which prolonged anaerobic conditions may be expected to occur or in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission:

— further studies to address the potential toxicological relevance of an impurity in the proposed technical specification;

— information to further clarify the occurrence of metabolite AE0608033 in primary crops and rotational crops;

— further trials on rotational crops (namely root crops and cereals) and a metabolism study on ruminants to confirm the consumer risk assessment;

— information to further address the risk to earthworm-eating birds and mammals, and the long-term risk to fish.

They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

178

Picloram

CAS No 1918-02-1

CIPAC No 174

4-amino-3,5,6-trichloropyridine-2-carboxylic acid

≥ 920 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In the overall assessment Member States must pay particular attention to:

— the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate;

The Member States concerned shall ensure that the notifier submits to the Commission:

— further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates;

— a soil photolysis study to confirm the evaluation of picloram degradation.

They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

▼M330 —————

▼B

180

Bifenox

CAS No 42576-02-3

CIPAC No 413

Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate

≥ 970 g/kg impurities:

max. 3 g/kg 2,4-dichlorophenol

max. 6 g/kg 2,4-dichloroanisole

1 January 2009

►M341  31 December 2021 ◄

►M85  
PART A
Only uses as herbicide may be authorised.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a)  the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;
(b)  the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops;
(c)  the environmental conditions leading to the potential formation of nitrofen.
Member States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c).  ◄

181

Diflufenican

CAS No 83164-33-4

CIPAC No 462

2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide

≥ 970 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

— the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate.

182

Fenoxaprop-P

CAS No 113158-40-0

CIPAC No 484

(R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid

≥ 920 g/kg

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of non target plants,

— the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure,

— the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur.

Conditions of authorisation should include risk mitigation measures, where appropriate.

183

Fenpropidin

CAS No 67306-00-7

CIPAC No 520

(R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine

≥ 960 g/kg (racemate)

1 January 2009

►M341  31 December 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone.

The Member States concerned shall request the submission of:

— information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

184

Quinoclamine

CAS No 2797-51-5

CIPAC No 648

2-amino-3-chloro-1,4-naphthoquinone

≥ 965 g/kg impurity:

dichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms,

— the protection of birds and small mammals.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

185

Chloridazon

CAS No 1698-60-8

CIPAC No 111

5-amino-4-chloro-2-phenylpyridazin-3(2H)-one

920 g/kg

The manufacturing impurity 4-amino-5-chloro-isomer is considered to be of toxicological concern and a maximum level of 60 g/kg is established.

1 January 2009

31 December 2018

PART A

Only uses as herbicide in application max. of 2,6 kg/ha only every third year on the same field may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chloridazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 December 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination from metabolites B and B1 in vulnerable zones, where appropriate.

186

Tritosulfuron

CAS No 142469-14-5

CIPAC No 735

1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea

≥ 960 g/kg

The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material:

2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg

1 December 2008

►M341  30 November 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of aquatic organisms,

— the protection of small mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

187

Flutolanil

CAS No 66332-96-5

CIPAC No 524

α,α,α-trifluoro-3′-isopropoxy-o-toluanilide

≥ 975 g/kg

1 March 2009

►M348  28 February 2022 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation should include risk mitigation measures, where appropriate.

188

Benfluralin

CAS No 1861-40-1

CIPAC No 285

N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine

≥ 960 g/kg

Impurities:

— ethyl-butyl-nitrosamine: max. 0,1 mg/kg

1 March 2009

►M348  28 February 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report onbenfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of the operators’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

— the protection of birds, mammals, surface waters and aquatic organisms. In relauion to these identified risks, sisk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the approval.

189

Fluazinam

CAS No 79622-59-6

CIPAC No 521

3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine

≥ 960 g/kg

Impurities:

5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine

— not more than 2 g/kg

1 March 2009

►M348  28 February 2022 ◄

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of the operators’ and workers’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

— the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the approval.

190

Fuberidazole

CAS No 3878-19-1

CIPAC No 525

2-(2′-furyl)benzimidazole

≥ 970 g/kg

1 March 2009

28 February 2019

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

191

Mepiquat

CAS No 15302-91-7

CIPAC No 440

1,1-dimethylpiperidinium chloride (mepiquat chloride)

≥ 990 g/kg

1 March 2009

►M348  28 February 2022 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.

192

Diuron

CAS No 330-54-1

CIPAC No 100

3-(3,4-dichlorophenyl)-1,1-dimethylurea

≥ 930 g/kg

1 October 2008

►M303  30 September 2020 ◄

PART A

Only uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety; conditions of use shall prescribe the use of personal protective equipment, if appropriate,

— the protection of aquatic organisms and non-target plants.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

193

Bacillus thuringiensis subsp. aizawai

STRAIN: ABTS-1857

Culture collection: No SD-1372,

STRAIN: GC-91

Culture collection: No NCTC 11821

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp.Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

194

Bacillus thuringiensis subsp. israeliensis (serotype H-14)

STRAIN: AM65-52

Culture collection: No ATCC-1276

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52(SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

195

Bacillus thuringiensis subsp. kurstaki

STRAIN: ABTS 351

Culture collection: No ATCC SD-1275

STRAIN: PB 54

Culture collection: No CECT 7209

STRAIN: SA 11

Culture collection: No NRRL B-30790

STRAIN: SA 12

Culture collection: No NRRL B-30791

STRAIN: EG 2348

Culture collection: No NRRL B-18208

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

196

Bacillus thuringiensis subsp. Tenebrionis

STRAIN: NB 176 (TM 141)

Culture collection: No SD-5428

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

197

Beauveria bassiana

STRAIN: ATCC 74040

Culture collection: No ATCC 74040

STRAIN: GHA

Culture collection: No ATCC 74250

Not applicable

Max level of beauvericin: 5 mg/kg

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

198

Cydia pomonella Granulovirus (CpGV)

Not applicable

►M122  Minimum concentration: 1 × 1013 OB/l (occlusion bodies/l) and Contaminating microorganisms (Bacillus cereus) in the formulated product < 1 × 107 CFU/g ◄

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M351 —————

▼B

200

Metarhizium anisopliae var. anisopliae

(formerly Metarhizium anisopliae)

STRAIN: BIPESCO 5/F52

Culture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M331

201

Phlebiopsis gigantea

STRAIN: VRA 1985

Culture collection: No DSM 16202

STRAIN: VRA 1986

Culture collection: No DSM 16203

STRAIN: FOC PG B20/5

Culture collection: No IMI 390096

STRAIN: FOC PG SP log 6

Culture collection: No IMI 390097

STRAIN: FOC PG SP log 5

Culture collection: No IMI 390098

STRAIN: FOC PG BU 3

Culture collection: No IMI 390099

STRAIN: FOC PG BU 4

Culture collection: No IMI 390100

STRAIN: FOC PG97/1062/116/1.1

Culture collection: No IMI 390102

STRAIN: FOC PG B22/SP1287/3.1

Culture collection: No IMI 390103

STRAIN: FOC PG SH 1

Culture collection: No IMI 390104

STRAIN: FOC PG B22/SP1190/3.2

Culture collection: No IMI 390105

Not applicable

No relevant impurities

1 May 2009

30 April 2020

PART A Only uses as fungicide may be authorised.

PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures.

▼B

202

Pythium oligandrum

STRAINS: M1

Culture collection No ATCC 38472

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

203

Streptomyces K61 (formerly S. griseoviridis)

STRAIN: K61

Culture collection: No DSM 7206

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

204

Trichoderma atroviride

(formerly T. harzianum)

STRAIN: IMI 206040

Culture collection No IMI 206040, ATCC 20476;

STRAIN: T11

Culture collection: No

Spanish type culture collection CECT 20498, identical with IMI 352941

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

205

Trichoderma polysporum

STRAIN: Trichoderma polysporum IMI 206039

Culture collection No IMI 206039, ATCC 20475

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

206

Trichoderma harzianum Rifai

STRAIN:

Trichoderma harzianum T-22;

Culture collection No ATCC 20847

STRAIN: Trichoderma harzianum ITEM 908;

Culture collection No CBS 118749

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

207

Trichoderma asperellum

(formerly T. harzianum)

STRAIN: ICC012

Culture collection No CABI CC IMI 392716

STRAIN: Trichoderma asperellum

(formerly T. viride T25) T25

Culture collection No CECT 20178

STRAIN: Trichoderma asperellum

(formerly T. viride TV1) TV1

Culture collection No MUCL 43093

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

208

Trichoderma gamsii (formerly T. viride)

STRAINS:

ICC080

Culture collection No IMI CC number 392151 CABI

Not applicable

No relevant impurities

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M316 —————

▼B

210

Abamectin

CAS No 71751-41-2

avermectin B1a

CAS No 65195-55-3

Avermectin B1b

CAS No 65195-56-4

abamectin

CIPAC No 495

AvermectinB1a

(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

AvermectinB1b

(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

≥ 850 g/kg

1 May 2009

►M322  30 April 2021 ◄

►M212

 

PART A

Only uses as insecticide, acaricide and nematicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information are provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 and of the addendum to the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed dated 24 January 2017 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the residues in food of plant origin and evaluate the dietary exposure of consumers,

— the protection of bees, non-target arthropods, soil organisms, birds, mammals and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones and waiting periods, should be applied where appropriate.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water by two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

 ◄

211

Epoxiconazole

CAS No 135319-73-2 (formerly 106325-08-0)

CIPAC No 609

(2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole

≥ 920 g/kg

1 May 2009

►M294  30 April 2020 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

— the dietary exposure of consumers to the epoxiconazole (triazole) metabolites,

— the potential for long-range transport via air,

— the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

The Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest.

The concerned Member States shall ensure that the notifier submits within two years from the approval, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals.

212

Fenpropimorph

CAS No 67564-91-4

CIPAC No 427

(RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

≥ 930 g/kg

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles.

The Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the approval.

213

Fenpyroximate

CAS No 134098-61-6

CIPAC No 695

tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate

> 960 g/kg

1 May 2009

►M322  30 April 2021 ◄

PART A

Only uses as acaricide may be authorised.

The following uses must not be authorised:

— applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall request the submission of information to further address:

— the risk to aquatic organisms from metabolites containing the benzyl moiety,

— the risk of biomagnification in aquatic food chains.

They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the approval.

214

Tralkoxydim

CAS No 87820-88-0

CIPAC No 544

(RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one

≥ 960 g/kg

1 May 2009

30 April 2019

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

— the protection of herbivorous mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of:

— information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim.

They shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the approval.

215

Aclonifen

CAS No 74070-46-5

CIPAC No 498

2-chloro-6-nitro-3-phenoxyaniline

≥ 970 g/kg

The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.

1 August 2009

►M199  31 July 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

— the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the residues in rotational crops and evaluate the dietary exposure of consumers,

— the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

216

Imidacloprid

CAS No 138261-41-3

CIPAC No 582

(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine

≥ 970 g/kg

1 August 2009

►M342  1 December 2020 ◄

►M261

 

PART A

Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 and the conclusions of the revised addendum of the review report on imidacloprid as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the risk to bees and bumble bees released for pollination in permanent greenhouses,

— the impact on aquatic organisms,

— the exposure of bees via the consumption of contaminated water from the permanent greenhouses.

Member States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised.

Conditions of use shall include risk mitigation measures, where appropriate.

 ◄

217

Metazachlor

CAS No 67129-08-2

CIPAC No 411

2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide

≥ 940 g/kg

The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established.

1 August 2009

►M199  31 July 2021 ◄

►M28

 

PART A

Only uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field.

 ◄

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.

If metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.

They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.

▼M74

218

Acetic acid

CAS No 64-19-7

CIPAC 838

acetic acid

≥ 980 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of operators, the protection of groundwater and the protection of aquatic organisms.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards:

— the acute and long-term risk to birds and mammals,

— the risk to honeybees,

— the risk to non-target arthropods.

The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2015.

▼M36

219

Aluminium ammonium sulphate

CAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous)

CIPAC No 840

Aluminium ammonium sulphate

≥ 960 g/kg (expressed as dodecahydrate)

≥ 502 g/kg (anhydrous)

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards:

(a)  the impact on the environment of the transformation/dissociation products of aluminium ammonium sulphate;

(b)  the risk to non-target terrestrial organisms other than vertebrates and aquatic organisms.

This information shall be submitted to the Member States, the Commission and the Authority by 1 January 2016.

▼M32

220

Aluminium silicate

CAS No 1332-58-7

CIPAC No 841

Not available

Chemical name: Aluminium silicate

≥ 999,8 g/kg

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium silicate (SANCO/2603/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operator safety; conditions of use shall include the application of adequate personal and respiratory protective equipment, where appropriate.

Conditions of use shall include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

(a)  the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;

(b)  the relevance of the test material used in the toxicity dossier in view of the specification of the technical material.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 1 May 2013.

▼B

221

Ammonium acetate

CAS No 631-61-8

CIPAC No not allocated

Ammonium acetate

≥ 970 g/kg

Relevant impurity: Heavy metals as Pb maximum 10 ppm

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M352 —————

▼M31

223

Calcium carbide

CAS No: 75-20-7

CIPAC No: 910

Calcium acetylide

≥ 765 g/kg

Containing 0,08 – 0,9 g/kg Calcium Phosphide

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

224

Calcium carbonate

CAS No: 471-34-1

CIPAC No: 843

Calcium carbonate

≥ 995 g/kg

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards:

— further data on the specification of the technical material,

— analytical methods for the determination of calcium carbonate in the representative formulation and of the impurities in the technical material.

These information shall be submitted to the Member States, the Commission and the Authority by 1 March 2013.

▼M66

225

Carbon dioxide

CAS No: 124-38-9

CIPAC No: 844

Carbon dioxide

≥ 99,9 %

Relevant impurities:

phosphane max. 0,3 ppm v/v

benzene max. 0,02 ppm v/v

carbon monoxide max. 10 ppm v/v

methanol max. 10 ppm v/v

hydrogen cyanide max. 0,5 ppm v/v

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as a fumigant may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M37

226

Denathonium benzoate

CAS No 3734-33-6

CIPAC No 845

Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate

≥ 975g/kg

1 September 2009

►M342  1 December 2020 ◄

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M49

227

Ethylene

CAS No 74-85-1

CIPAC No 839

Ethylene

≥ 90 %

Relevant impurity: ethylene oxide, max content 1 mg/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only indoor uses as plant growth regulator by professional users may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)  the compliance of ethylene with the required specifications, irrespective of the form in which it is supplied to the user;

(b)  the protection of operators, workers and bystanders.

Conditions of authorisation shall include, where appropriate, risk mitigation measures.

▼M106

228

Extract from tea tree

CAS No Tea Tree Oil 68647-73-4

Main components:

terpinen-4-ol 562-74-3

γ-terpinene 99-85-4

α-terpinene 99-86-5

1,8-cineole 470-82-6

CIPAC No 914

Tea Tree Oil is a complex mixture of chemical substances.

Main components:

terpinen-4-ol ≥ 300 g/kg

γ-terpinene ≥ 100 g/kg

α-terpinene ≥ 50 g/kg

1,8-cineole ≥ 1 g/kg

Relevant impurity:

Methyl eugenol: maximum 1 g/kg of the technical material

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as fungicide in greenhouse may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on extract from tea tree (SANCO/2609/2008 final) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to

— the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

— the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

— the protection of surface water and aquatic organisms;

— the protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The notifier shall submit confirmatory information as regards:

(a)  the plant metabolism and consumer exposure;

(b)  the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol;

(c)  the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products;

(d)  the effects on biological methods of sewage treatment.

The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 at latest.

▼M36

229

Fat distillation residues

CAS No: not allocated

CIPAC No 915

Not available

≥ 40 % of cleaved fatty acids

Relevant impurity: Ni maximum 200 mg/kg

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as repellent may be authorised. Fat distillation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 (OJ L 54, 26.2.2011, p. 1).

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on fat distillation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.

▼B

230

Fatty acids C7 to C20

CAS No 112-05-0 (Pelargonic Acid)

67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)

124-07-2 (Caprylic Acid)

334-48-5 (Capric Acid)

143-07-7 (Lauric Acid)

112-80-1 (Oleic Acid)

85566-26-3 (Fatty acids C8-C10 Me esters)

111-11-5 (Methyl octanoate)

110-42-9 (Methyl decanoate)

CIPAC No not allocated

Nonanoic acid

Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)

Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)

Fatty acids, C7-C10, Me esters

≥ 889 g/kg (Pelargonic Acid)

≥ 838 g/kg fatty acids

≥ 99 % fatty acid methyl esters

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M350 —————

▼B

232

Gibberellic acid

CAS No 77-06-5

CIPAC No 307

(3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid

Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid

≥ 850 g/kg

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

233

Gibberellins

CAS No GA4: 468-44-0

GA7: 510-75-8

GA4A7 mixture: 8030-53-3

CIPAC No not allocated

GA4:

(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid

GA7:

(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid

Review report (SANCO/2614/2008).

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M32

234

Hydrolysed proteins

CAS No not allocated

CIPAC No 901

Not available

Review report (SANCO/2615/2008)

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 (17) and Commission Regulation (EU) No 142/2011 (18).

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hydrolysed proteins (SANCO/2615/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operator and worker safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate.

Conditions of use shall include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

(a)  the specifications of the technical material, as commercially manufactured, supported by appropriate analytical data;

(b)  the risk to aquatic organisms.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013, the information set out in point (b) by 1 November 2013.

▼M38

235

Iron sulphate:

Iron(II)sulfate anhydrous: CAS No 7720-78-7

Iron(II)sulfate monohydrate: CAS No 17375-41-6

Iron(II)sulfate heptahydrate: CAS No 7782-63-0

CIPAC No 837

Iron(II)sulphate

or

iron(2+) sulfate

Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron.

Relevant impurities:

arsenic, 18 mg/kg

cadmium, 1,8 mg/kg

chromium, 90 mg/kg

lead, 36 mg/kg

mercury, 1,8 mg/kg

expressed on the basis of the anhydrous variant

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

— the risk for operator;

— the risk to children/residents playing on treated turf;

— the risk to surface waters and to aquatic organisms.

Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers.

The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013.

▼M345 —————

▼M31

237

Limestone

CAS No: 1317-65-3

CIPAC No: 852

Calcium carbonate

≥ 980 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M217 —————

▼M31

239

Pepper dust extraction residue (PDER)

CAS No: not allocated

CIPAC No: not allocated

Steam distilled and solvent extracted Black pepper – Piper nigrum

It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %

1 September 2009

►M296  31 August 2019 ◄

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing pepper dust extraction residue (PDER) for uses other than in home garden area, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures

The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.

▼M115

240

Plant oils/citronella oil

CAS No 8000-29-1

CIPAC No 905

Citronella Oil is a complex mixture of chemical substances.

The main components are:

Citronellal (3,7-dimethyl-6-octenal).

Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).

Citronellol (3,7-dimethyl-6-octan-2-ol).

Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).

The sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol.

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

In this overall assessment Member States shall pay particular attention to:

— the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

— the protection of groundwater, when the substance is applied in regions with vulnerable soil;

— the risk to non-target organisms.

The notifier shall submit confirmatory information as regards:

(a)  the technical specification;

(b)  data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms;

(c)  the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol.

The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016.

▼M100

241

Plant oils/clove oil

CAS No 84961-50-2 (clove oil)

97-53-0 (Eugenol — main component)

CIPAC No 906

Clove Oil is a complex mixture of chemical substances.

The main component is eugenol.

≥ 800 g/kg

Relevant impurity: methyl eugenol maximum 0,1 % of the technical material

1 September 2009

►M199  31 August 2022 ◄

PART A

Only indoor uses as post-harvest fungicide and bactericide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.

The notifier shall submit confirmatory information as regards

(a)  the technical specification;

(b)  data comparing natural background exposure situations of plant oils/clove oil, eugenol and methyl eugenol in relation to exposure from the use of plant oils/clove oil as a plant protection product. This data shall cover human exposure.

The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016.

▼M87

242

Plant oils/rape seed oil

CAS No: 8002-13-9

CIPAC No: not allocated

Rape seed oil

Rape seed oil is a complex mixture of fatty acids

Relevant impurity: Maximum 2 % of erucic acid

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M37

243

Plant oils/spear mint oil

CAS No 8008-79-5

CIPAC No 908

Spearmint oil

≥ 550 g/kg as (R)-Carvone

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as plant growth regulator for postharvest treatment of potatoes may be authorised.

Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M39

244

Potassium hydrogen carbonate

CAS No 298-14-6

CIPAC No 853

Potassium hydrogen carbonate

≥ 99,5 %

Impurities:

Pb max. 10 mg/kg

As max. 3 mg/kg

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as fungicide and insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures.

▼M32

245

1,4-diaminobutane (putrescine)

CAS No 110-60-1

CIPAC No 854

Butane-1,4-diamine

≥ 990 g/kg

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1,4-diaminobutane (putrescine) (SANCO/2626/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M75

246

Pyrethrins: 8003-34-7

CIPAC No 32

Extract A: extractives of Chrysanthemum cinerariaefolium:

89997- 63-7

Pyrethrin 1: CAS 121- 21-1

Pyrethrin 2: CAS 121- 29-9

Cinerin 1: CAS 25402- 06-6

Cinerin 2: CAS 121- 20-0

Jasmolin 1: CAS 4466- 14-2

Jasmolin 2: CAS 1172- 63-0

Extract B:

Pyrethrin 1: CAS 121-21-1

Pyrethrin 2: CAS 121- 29-9

Cinerin 1: CAS 25402- 06-6

Cinerin 2: CAS 121- 20-0

Jasmolin 1: CAS 4466- 14-2

Jasmolin 2: CAS 1172- 63-0

Pyrethrins are a complex mixture of chemical substances.

Extract A: ≥ 500 g/kg Pyrethrins

Extract B: ≥ 480 g/kg Pyrethrins

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)  the risk to operators and workers;

(b)  the risk to non-target organisms.

Conditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures.

The applicant shall submit confirmatory information as regards:

(1)  the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies;

(2)  the risk from inhalation;

(3)  the residue definition;

(4)  the representativeness of the major component ‘pyrethrin 1’ as regards the fate and behaviour in soil and water.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December 2015.

▼M31

247

Quartz sand

CAS No: 14808-60-7, 7637-86-9

CIPAC No: 855

Quartz, Silicon dioxide

≥ 915 g/kg

Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing quartz sand for uses other than on trees in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M36

248

Fish oil

CAS No 100085-40-3

CIPAC No 918

Fish oil

≥ 99 %

Relevant impurity:

Dioxine max. 6 pg/kg for animal feed

Hg max. 0,5 mg/kg feed derived from fish and other sea food processing

Cd max. 2 mg/kg feed of animal origin except in feed for domestic pets

Pb max. 10 mg/kg

PCBs max. 5 mg/kg

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.

▼B

249

Repellents by smell of animal or plant origin/sheep fat

CAS No 98999-15-6

CIPAC No not allocated

Sheep Fat

Pure sheep fat containing a maximum of 0,18 % w/w/water.

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1069/2009

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M230 —————

▼M229 —————

▼B

252

Sea-algae extract (formerly sea algae extract and sea weeds)

CAS No not allocated

CIPAC No not allocated

See algae extract

See algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

253

Sodium aluminium silicate

CAS No 1344-00-9

CIPAC No not allocated

Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O

1 000  g/kg

1 September 2009

►M296  31 August 2019 ◄

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M51

254

Sodium hypochlorite

CAS No: 7681-52-9

CIPAC: 848

Sodium hypochlorite

Sodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate

10-12 % (w/w) expressed as chlorine

1 September 2009

31 August 2019

PART A

Only indoor uses as disinfectant may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)  the risk to operator and workers;

(b)  the exposure of soil to sodium hypochlorite and its reaction products through spreading of treated compost on organic land shall be avoided.

Conditions of use shall include risk mitigation measures, where appropriate.

▼M127

255

Straight Chain Lepidopteran Pheromones

Review report (SANCO/2633/2008)

Review report (SANCO/2633/2008)

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as attractants may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards:

(1)  the genotoxic profile of aldehyde group compounds;

(2)  exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016.

▼B

256

Trimethylamine hydrochloride

CAS No 593-81-7

CIPAC No not allocated

Trimethylamine hydrochloride

≥ 988 g/kg

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

▼M36

257

Urea

CAS No 57-13-6

CIPAC No 913

Urea

≥ 98 % w/w

1 September 2009

►M334  31 August 2021 ◄

PART A

Only uses as attractant and fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The notifier shall submit confirmatory information as regards:

(a)  the analysis method for urea and for the impurity biuret;

(b)  the risk for operators, workers and bystanders.

The information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016.

▼M180 —————

▼M179 —————

▼B

260

Aluminium phosphide

CAS No 20859-73-8

CIPAC No 227

Aluminium phosphide

≥ 830 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use aluminium phosphide containing products may be authorised.

As rodenticide, talpicide and leporicide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

— the protection of operators and workers during fumigation for indoor uses;

— the protection of workers at re-entry (after fumigation period) for indoor uses;

— the protection of bystanders against leaking of gas for indoor uses;

— the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

— the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

261

Calcium phosphide

CAS No 1305-99-3

CIPAC No 505

Calcium phosphide

≥ 160 g/kg

1 September 2009

►M342  1 December 2020 ◄

PART A

Only outdoor uses as rodenticide and talpicide in the form of ready-to-use calcium phosphide containing products may be authorised.

Authorisations should be limited to professional users.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

— the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

— the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

262

Magnesium phosphide

CAS No 12057-74-8

CIPAC No 228

Magnesium phosphide

≥ 880 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use magnesium phosphide containing products may be authorised.

As rodenticide, talpicide and leporicide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

— the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

— the protection of operators and workers during fumigation for indoor uses;

— the protection of workers at re-entry (after fumigation period) for indoor uses;

— the protection of bystanders against leaking of gas for indoor uses;

— the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

— the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

263

Cymoxanil

CAS No 57966-95-7

CIPAC No 419

1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea

≥ 970 g/kg

1 September 2009

►M199  31 August 2021 ◄

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

— the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

264

Dodemorph

CAS No 1593-77-7

CIPAC No 300

cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine

≥ 950 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as fungicide on ornamentals in glasshouse may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions;

— conditions of authorisation should include risk mitigation measures, where appropriate.

265

2,5-Dichlorobenzoic acid methylester

CAS No 2905-69-3

CIPAC No 686

methyl-2,5-dichlorobenzoate

≥ 995 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

266

Metamitron

CAS No 41394-05-2

CIPAC No 381

4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one

≥ 960 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate;

— the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

— the risk to birds and mammals, and non-target terrestrial plants.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

267

Sulcotrione

CAS No 99105-77-8

CIPAC No 723

2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione

≥ 950 g/kg

Impurities:

— hydrogen cyanide: not more than 80 mg/kg

— toluene: not more than 4 g/kg

1 September 2009

►M199  31 August 2022 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

— the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

268

Tebuconazole

CAS No 107534-96-3

CIPAC No 494

(RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol

≥ 905 g/kg

1 September 2009

►M334  31 August 2021 ◄

►M128

 

PART A

Only uses as fungicide and plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

— the dietary exposure of consumers to the tebuconazole (triazole) metabolites;

— the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole;

— the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

— the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

 ◄

269

Triadimenol

CAS No 55219-65-3

CIPAC No 398

(1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

≥ 920 g/kg

isomer A (1RS,2SR), isomer B (1RS,2RS)

Diastereomer A, RS + SR, range: 70 to 85 %

Diastereomer B, RR + SS, range: 15 to 30 %

1 September 2009

31 August 2019

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure;

— the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission:

— further information on the specification;

— information to further address the risk assessment for birds and mammals.

— information to further address the risk of endocrine disrupting effects on fish.

They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

270

Methomyl

CAS No 16752-77-50

CIPAC No 264

S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate

≥ 980 g/kg

1 September 2009

31 August 2019

PART A

Only uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season.

Authorisations shall be limited to professional users.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

— the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment,

— the protection of birds,

— the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles,

— the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied.

Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents.

Where appropriate, conditions of authorisation shall include further risk mitigation measures.

271

Bensulfuron

CAS No 83055-99-6

CIPAC No 502.201

α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron)

methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl)

≥ 975 g/kg

1 November 2009

►M213  31 October 2022 ◄

PART A

Only uses as a herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to the following:

— the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

— the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions.

The Member States concerned shall ensure that the notifier submits to the Commission:

— further studies on the specification,

— information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions,

— information to address the relevance of metabolites for the consumer risk assessment.

They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

272

Sodium 5-nitroguaiacolate

CAS No 67233-85-6

CIPAC number not allocated

Sodium 2-methoxy-5-nitrophenolate

≥ 980 g/kg

1 November 2009

►M213  31 October 2022 ◄

PART A

Only use as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

— the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

273

Sodium o-nitrophenolate

CAS No 824-39-5

CIPAC number not allocated

Sodium 2-nitrophenolate; sodium o-nitrophenolate

≥ 980 g/kg

The following impurities are of toxicological concern:

Phenol

Max content: 0,1 g/kg

2,4 dinitrophenol

max content: 0,14 g/kg

2,6 dinitrophenol

max content: 0,32 g/kg

1 November 2009

►M213  31 October 2022 ◄

PART A

Only use as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

— the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

274

Sodium p-nitrophenolate

CAS No 824-78-2

CIPAC number not allocated

Sodium 4-nitrophenolate; sodium p-nitrophenolate

≥ 998 g/kg

The following impurities are of toxicological concern:

Phenol

max content: 0,1 g/kg

2,4 dinitrophenol

max content: 0,07 g/kg

2,6 dinitrophenol

max content: 0,09 g/kg

1 November 2009

►M213  31 October 2022 ◄

PART A

Only use as plant growth regulator may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

— the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

— the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

275

Tebufenpyrad

CAS No 119168-77-3

CIPAC No 725

N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide

≥ 980 g/kg

1 November 2009

►M213  31 October 2022 ◄

PART A

Only uses as acaricide and insecticide may be authorised.

PART B

In assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

— the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the notifier submits to the Commission:

— further information confirming that no relevant impurities are present,

— information to further address the risk to insectivorous birds.

They shall ensure that the notifier provides such information to the Commission by 31 October 2011.

276

Chlormequat

CAS No 7003-89-6 (chlormequat)

CAS No 999-81-5 (chlormequat chloride)

CIPAC No 143 (chlormequat)

CIPAC No 143.302 (chlormequat chloride)

2-chloroethyltrimethylammonium (chlormequat)

2-chloroethyltrimethylammonium chloride

(chlormequat chloride)

≥ 636 g/kg

Impurities

1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content)

Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content)

1 December 2009

►M213  30 November 2021 ◄

PART A

Only uses as plant growth regulator on cereals and non edible crops may be authorised.

PART B

In assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

— the protection of birds and mammals.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.

▼M288 —————

▼B

278

Propaquizafop

CAS No 111479-05-1

CIPAC No 173

2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate

≥ 920 g/kg

Toluene maximum content 5 g/kg

1 December 2009

►M213  30 November 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

— the protection of non-target arthropods and ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the notifier submits to the Commission:

— further information on the relevant impurity Ro 41-5259,

— information to further address the risk to aquatic organisms and to non-target arthropods.

They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

▼M213

279

Quizalofop-P

 

 

Quizalofop-P-tefuryl

CAS No 119738-06-6

CIPAC No 641.226

(RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate

≥ 795 g/kg

1 December 2009

►M238  30 November 2021 ◄

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

— the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.

They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

Quizalofop-P-ethyl

CAS No 100646-51-3

CIPAC No 641.202

ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate

≥ 950 g/kg

1 December 2009

30 November 2021

▼B

280

Teflubenzuron

CAS No 83121-18-0

CIPAC No 450

1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea

≥ 970 g/kg

1 December 2009

30 November 2019

PART A

Only uses as insecticide in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised.

PART B

In assessing applications to authorise plant protection products containing teflubenzuron for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on teflubenzuron, and in particular Appendices I and II thereof, as finalis